To estimate the maximum tolerated dose (MTD) of ABT-888 in combination with Temozolomide in children with recurrent or refractory CNS tumors

-To study the plasma pharmacokinetics (PK) of ABT-888 and PARPinhibition in peripheral blood mononuclear cells (PBMC) in order torecommend a Phase 2 dose of ABT-888 in combination with temozolomide in children with recurrent or refractory ...

Maximum-tolerated dose of lenalidomide with cetuximab, defined as the highest dose level at which 0 or 1 patients out of 6 experiences a dose limiting toxicity graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

The Proportion of Patients Who Achieve a Confirmed Objective Response to Treatment, Either Partial Response (PR) or Complete Response (CR) as Defined by Response Evaluation Criteria In Solid Tumors (RECIST) Criteria

Overall Survival

Progression-free Survival

29

All

18 Years and older (Adult, Older Adult)

NCT00848016

NCI-2009-01160MC07718035CDR0000635024N01CM00070N01CM00038

February 2009

March 2012

June 2012

February 20, 2009

May 7, 2014

February 21, 2014

University of Southern CaliforniaLos Angeles, California, United States

MTD of talazoparib and temozolomide, defined as the maximum dose at which fewer than one-third of patients experience dose limiting toxicities (Phase I Part A1)

Objective response in patients with Ewing sarcoma or peripheral PNET assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 and criteria for CNS tumors (Phase I Part A2)

Incidence of adverse events during paclitaxel and carboplatin treatment according to dose-limiting toxicities (DLTs), graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)

Response rates in patients with lung, head and neck, and esophageal cancers assessed by Response Evaluation Criteria for Solid Tumors (RECIST) 1.1

Effects of therapy on HIV viral load and CD4 cell count

17

All

18 Years and older (Adult, Older Adult)

NCT01249443

AMC-078NCI-2011-02511CDR0000689900U01CA121947

November 2013

May 2016

December 2017

November 29, 2010

December 21, 2017

UC San Diego Moores Cancer CenterLa Jolla, California, United States

UCLA Center for Clinical AIDS Research and EducationLos Angeles, California, United States

Lombardi Comprehensive Cancer Center at Georgetown UniversityWashington, District of Columbia, United States